CN101322695B - Piclofenac potassium sustained release capsule and preparing technique thereof - Google Patents
Piclofenac potassium sustained release capsule and preparing technique thereof Download PDFInfo
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- CN101322695B CN101322695B CN2008101348257A CN200810134825A CN101322695B CN 101322695 B CN101322695 B CN 101322695B CN 2008101348257 A CN2008101348257 A CN 2008101348257A CN 200810134825 A CN200810134825 A CN 200810134825A CN 101322695 B CN101322695 B CN 101322695B
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- diclofenac potassium
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Abstract
The invention provides a diclofenac potassium sustained-release capsule which is anti-inflammation and analgesic drug, and a production method thereof. The diclofenac potassium sustained-release capsule is formed by preparing diclofenac potassium into sustained-release pellets and then filling the pellets into the capsule; the diclofenac potassium sustained-release pellet consists of a blank pellet core taken as mother nucleus, a main drug layer which is coated outside of the pellet core and contains diclofenac potassium and a sustained-release coating layer covered on the main drug layer. The diclofenac potassium sustained-release capsule of the invention has fine preparation stability and prominent release effect.
Description
Technical field
The present invention relates to a kind of slow releasing preparation, specifically, relate to a kind of Piclofenac potassium sustained release capsule and production method thereof, belong to medical technical field.
Background technology
Diclofenac potassium is a nonsteroidal antiinflammatory drug, and its active ingredient is a diclofenac, and is main by suppressing synthetic analgesia, antiinflammatory, the refrigeration function of producing of prostaglandin.Rheumatic arthritis, rheumatoid arthritis, degenerative osteoarthritis, gout, periarticular soft tissues inflammation, the caused arthralgia of damage had the good curing effect.Its curative effect is better than other steroidal class medicines such as indometacin, aspirin, ibuprofen, naproxen, and absorb fast, few side effects, the intestines and stomach reaction is lighter than most of nonsteroidal antiinflammatory drugs, better tolerance, dosage is little, and individual variation is little, so be widely used in more than 120 countries and regions, countries in the world at present.
The dosage form of the present domestic listing of diclofenac potassium has tablet and capsule, its usage and dosage is: be grown up 100-150mg/ days (2-3 grain/sky), the person of being in a bad way can reach 200mg/ days (4/day), every day, repeatedly frequent medication brought very big inconvenience to the patient, and blood drug level is not steady, peak valley phenomenon occurs, the medication of high dose has produced very big toxic and side effects.
Slow releasing preparation can make the slow according to certain rules non-constant release of medicine, and medicine is the long period drug level of remaining valid in vivo, thereby reaches the minimizing drug dose, improves drug effect, prolong drug action time and reduce the purpose of adverse effect.The research of slow releasing preparation and production have caused extensive attention both domestic and external, become the focus of developmental research.The Piclofenac potassium sustained release medicine is provided, and the patient takes and stores conveniently, has reached efficient, safety, reasonable target.
Summary of the invention
The object of the present invention is to provide a kind of Piclofenac potassium sustained release capsule and production method thereof.Piclofenac potassium sustained release capsule of the present invention has significantly reduced administration number of times and accumulated dose, has reduced toxic and side effects.
The technical scheme that the present invention solves comprises:
Filled capsules formed after Piclofenac potassium sustained release capsule of the present invention was made slow-release micro-pill by diclofenac potassium.
The invention provides a kind of diclofenac potassium sustained-release pellet, its by as the celphere of parent nucleus, be wrapped in the outer principal agent layer that contains diclofenac potassium of ball core and be wrapped in the outer sustained release coating layer of principal agent layer and form, it is characterized in that counting by weight percentage, celphere 30%～60%, principal agent layer 20%～35%, sustained release coating layer 20%～35%.
Above-mentioned described diclofenac potassium sustained-release pellet, wherein said principal agent layer is by diclofenac potassium, filler and optionally exist binding agent to make, and count by weight percentage, contain diclofenac potassium 50%～80%, filler 10%～30%, binding agent 0～30% in the principal agent layer.
Wherein, above-mentioned described diclofenac potassium sustained-release pellet, described sustained release coating layer is made by slow releasing agent, antiplastering aid, the optional porogen that exists, the optional plasticizer that exists, the optional opacifier that exists, and porogen and plasticizer exist one of at least in the two, count by weight percentage, contain slow releasing agent 60%～85%, antiplastering aid 5%～30%, porogen 0～10%, plasticizer 0～10%, opacifier 0～10% in the sustained release coating layer.
As the preferred embodiment of the invention, described diclofenac potassium sustained-release pellet, wherein said slow releasing agent are selected from ethyl cellulose, acrylic resin, the cellulose acetate one or more.
As optimal way, the above-mentioned diclofenac potassium sustained-release pellet of the present invention, wherein:
Described filler is selected from lactose, sucrose, starch, DI-CALCIUM PHOSPHATE, mannitol, sorbitol, microcrystalline Cellulose and the Pulvis Talci one or more;
Described antiplastering aid is selected from Pulvis Talci, magnesium stearate, micropowder silica gel and the sodium lauryl sulphate one or more;
Described porogen is selected from hypromellose, hyprolose, polyethylene glycol 6000 and the polyvidone one or more;
Described plasticizer is selected from glycerol, propylene glycol, polyethylene glycols, citron triethylenetetraminehexaacetic acid fat, dimethyl phthalate, triacetin and the Oleum Ricini one or more;
Described binding agent is selected from sodium carboxymethyl cellulose, polyvidone, hypromellose and the sucrose one or more;
Described opacifier is a titanium dioxide.
Diclofenac potassium sustained-release pellet of the present invention, wherein said celphere is made up of sucrose or starch, also can be made up of microcrystalline Cellulose; The size of described celphere is preferably 0.35～1.12mm, more preferably 0.6～0.9mm.
Another purpose of the present invention provides a kind of Piclofenac potassium sustained release capsule, it is characterized in that loading the capsule that forms by above-mentioned described diclofenac potassium sustained-release pellet.Piclofenac potassium sustained release capsule of the present invention, its specification can be determined as required.Contain diclofenac potassium 50～200mg, more preferably 100mg in the preferred every capsules of the present invention.
The present invention also provides a kind of method for preparing described Piclofenac potassium sustained release capsule, it is characterized in that comprising the steps:
(1) celphere is joined in the comminutor, spray ethanol or water or binder solution moistening, add the mixture of principal agent and filler again, make ganoid pastille micropill; Perhaps use dissolve with ethanol solution principal agent, filler, the binding agent of suitable concn, make coating solution, celphere is joined in the comminutor, the coating solution that sprinkling prepares gets the pastille micropill in the celphere surface after the drying;
(2) with dissolve with ethanol solution slow releasing agent, porogen, plasticizer, antiplastering aid, the opacifier of suitable concn, make sustained release coating liquid;
(3) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, get diclofenac potassium sustained-release pellet after the drying;
(4) diclofenac potassium sustained-release pellet that step (3) is made incapsulates in the shell, gets Piclofenac potassium sustained release capsule.
Wherein, in the above-mentioned described method, described alcoholic solution is preferably 60%～95% alcoholic solution.
The above-mentioned described method of the present invention; wherein the preparation of slow-release micro-pill can adopt in the pharmaceuticals industry suitable facility for granulating to carry out, and for example can adopt centrifugal coating pelletizing machine, High Speed Stirring Machine, extrudes spheronizator, fluidized bed coating granulator or the preparation of efficient film coating pan.
The present invention is directed to the diclofenac potassium active pharmaceutical ingredient, by a large amount of experimental studies, found diclofenac potassium sustained-release pellet composition of the present invention and technology, and then made Piclofenac potassium sustained release capsule to have good preparation stability, outstanding good release profiles.The present invention can overcome and take blood drug level peak, the paddy phenomenon that conventional capsule is taken the back appearance by the Piclofenac potassium sustained release capsule of preparation, can keep balance, persistent effective blood drug concentration in equal dosage and interval, thereby increase curative effect; Or reduce dosage when keeping equal drug effect, take the side effect that medicine brings to the patient thereby reduce.According to the diclofenac potassium usage and dosage, be grown up 100-150mg/ days (2-3 grain/sky), the person of being in a bad way can reach 200mg/ days (4/day), and the present invention makes slow releasing capsule with diclofenac potassium, has reduced administration number of times effectively, can keep drug effect concentration for a long time, reached long lasting purpose, and preparation technology is simple, production cost is low, take and store conveniently, also reduced the toxic and side effects of medicine simultaneously.
Beneficial effect below by description of test technical scheme provided by the present invention.
Drug release determination: get this product, according to drug release determination method (two appendix X of Chinese Pharmacopoeia version in 2000 D, second method), adopt the device of dissolution method (two appendix X of Chinese Pharmacopoeia version in 2000 C, second method), 900ml is a solvent with phosphate buffer (pH value 7.4), rotating speed is that per minute 100 changes, operation was in accordance with the law got solution 5ml respectively and is filtered at 2 hours, 6 hours, 12 hours, and replenished above-mentioned solution 5ml immediately in process container; Precision is measured each 2ml of subsequent filtrate respectively, place 5ml (50mg specification) or 10ml (100mg specification) or 20ml (200mg specification) measuring bottle respectively, add above-mentioned solvent dilution to scale, shake up, measure according to ultraviolet spectrophotometry (two appendix IVA of Chinese Pharmacopoeia version in 2000), measure trap respectively at the wavelength place of 276nm; Other precision takes by weighing through 105 ℃ of diclofenac potassium reference substances that are dried to constant weight an amount of, adds above-mentioned dissolution with solvents and quantitatively is diluted to the solution that contains 20 μ g among every 1ml approximately, measures trap with method.Calculate every stripping quantity respectively at different time.Every burst size of this product at 2 hours, 6 hours, 12 hours should should be mutually respectively labelled amount 15%～40%, 40%～70%, more than 70%, all should be up to specification.
Assay: the chromatographic condition octadecylsilane chemically bonded silica is a filler, is mobile phase with methanol-water-glacial acetic acid (80: 20: 0.8), detects wavelength 257nm.According to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2000
D) measure, this product contains diclofenac potassium and should be 90.0%～110.0% of labelled amount.
Determination of related substances: press the chromatographic condition under the assay item, according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2000
D) measure, the total impurities of this product must not be greater than 1.0%.
Detect according to the sample of above-mentioned detection method, carry out study on the stability then, thereby embody quality of the pharmaceutical preparations stability of the present invention embodiment of the invention preparation.
The Piclofenac potassium sustained release capsule prepared to embodiment 1-4 carries out quality testing.Carried out under 40 ℃ of high temperature, relative humidity 75% ± 5% condition accelerated test simultaneously 6 months and 25 ℃ of temperature, relative humidity 60% ± 10% condition under 18 months investigation of long term test, detect the variation of every quality index, the gained data are shown in table 1-3:
Table 10 day quality testing result
Accelerated test is 6 months under 40 ℃ of table 2 high temperature, relative humidity 75% ± 5% condition
Long term test is 18 months under 25 ℃ of table 3 temperature, relative humidity 60% ± 10% condition
By above data result as can be seen, the Piclofenac potassium sustained release capsule quality conformance with standard requirement that the present invention makes, and through acceleration to wait in 6 months and long-term 18 months test after, every quality index does not have significant change, all meet quality standard, illustrated that the sample quality stability of preparation of the present invention is fine.
With 0 day release data instance of embodiment 1 sample, do cumulative release amount-time graph, the results are shown in accompanying drawing 1.
Description of drawings
Fig. 1: embodiment 1 sample cumulative release amount-time graph
The specific embodiment
Embodiment 1 Piclofenac potassium sustained release capsule
Diclofenac potassium 100mg
Celphere 300mg
Starch 33mg
Ethyl cellulose 96mg
Polyethylene glycol 6000 8mg
Pulvis Talci 15mg
Titanium dioxide 3mg
Preparation process is:
(1) the 300g celphere is joined in the comminutor, spray an amount of ethanol moistening, add the mixture of 100g diclofenac potassium and 33g starch, handle and made ganoid pastille micropill in 30 minutes;
(2) with 95% dissolve with ethanol solution 96g ethyl cellulose and 8g polyethylene glycol 6000,15g Pulvis Talci, 3g titanium dioxide, make sustained release coating liquid;
(3) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, then the slow-release micro-pill of gained is placed 70 ℃ vacuum drying oven inner drying 2 hours, slow-release micro-pill;
(4) content and the release of detection slow-release micro-pill, loading amount is calculated in qualified back, in the corresponding capsule shells of packing into, gets Piclofenac potassium sustained release capsule.
Diclofenac potassium 100mg
Celphere 300mg
Hypromellose 10mg
Pulvis Talci 15mg
Acrylic resin 120mg
Glycerol 13mg
Micropowder silica gel 15mg
Titanium dioxide 3mg
Preparation process is:
(1) with 70% dissolve with ethanol solution 100g diclofenac potassium and 10g hypromellose, 15g Pulvis Talci, makes the coating suspension;
(2) the 300g celphere is joined in the comminutor, the coating suspension that sprinkling prepares is in the celphere surface, and 45 ℃ of vacuum dryings get the pastille micropill then;
(3) with 40～80% dissolve with ethanol solution 120g acrylic resins and 13g glycerol, 15g micropowder silica gel, 3g titanium dioxide, make sustained release coating liquid;
(4) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, then the slow-release micro-pill of gained is placed 45 ℃ vacuum drying oven inner drying 5 hours, slow-release micro-pill;
(5) content and the release of detection slow-release micro-pill, loading amount is calculated in qualified back, in the corresponding capsule shells of packing into, gets Piclofenac potassium sustained release capsule.
Embodiment 3 Piclofenac potassium sustained release capsules
Diclofenac potassium 200mg
Celphere 300mg
Lactose 45mg
Microcrystalline Cellulose 37mg
Cellulose acetate 132mg
Polyvidone 21mg
Citron triethylenetetraminehexaacetic acid fat 22mg
Pulvis Talci 34mg
Preparation process is:
(1) the 300g celphere is joined in the comminutor, spray an amount of 80% alcoholic solution moistening, add the mixture of 200g diclofenac potassium and 45g lactose, 37g microcrystalline Cellulose, locate to make in 90 minutes ganoid pastille micropill;
(2) with 60%～95% dissolve with ethanol solution 153g cellulose acetate and 22g citron triethylenetetraminehexaacetic acid fat, 21g polyvidone, 34g Pulvis Talci, make sustained release coating liquid;
(3) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, then the slow-release micro-pill of gained is placed 60 ℃ vacuum drying oven inner drying 4 hours, slow-release micro-pill;
(4) content and the release of detection slow-release micro-pill, loading amount is calculated in qualified back, in the corresponding capsule shells of packing into, gets Piclofenac potassium sustained release capsule.
Diclofenac potassium 50mg
Celphere 200mg
Polyvidone 20mg
Pulvis Talci 15mg
Ethyl cellulose 87mg
Hypromellose 5mg
Triacetin 8mg
Magnesium stearate 10mg
Preparation process is:
(1) with 60～80% dissolve with ethanol solution 50g diclofenac potassiums and 20g polyvidone, 15g Pulvis Talci, makes the coating suspension;
(2) the 200g celphere is joined in the comminutor, the coating suspension that sprinkling prepares is in the celphere surface, and 50 ℃ of vacuum dryings get the pastille micropill then;
(3) with 95% dissolve with ethanol solution 87g acrylic resin and 8g triacetin, 5g hypromellose, 10g magnesium stearate, make sustained release coating liquid;
(4) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, then the slow-release micro-pill of gained is placed 50 ℃ vacuum drying oven inner drying 3 hours, slow-release micro-pill;
(5) content and the release of detection slow-release micro-pill, loading amount is calculated in qualified back, in the corresponding capsule shells of packing into, gets Piclofenac potassium sustained release capsule.
The present invention is described according to preferred embodiment.Should be understood that the description of front and embodiment are just to illustrating the present invention.Under prerequisite without departing from the spirit and scope of the present invention, those skilled in the art can design multiple alternative of the present invention and improvement project, and it all should be understood to be within protection scope of the present invention.
Claims (9)
1. diclofenac potassium sustained-release pellet, it is by the celphere as parent nucleus, be wrapped in the outer principal agent layer that contains diclofenac potassium of ball core and be wrapped in the outer sustained release coating layer of principal agent layer and form, it is characterized in that: celphere 30%～60%, principal agent layer 20%～35%, sustained release coating layer 20%～35%, wherein, described principal agent layer is by diclofenac potassium, filler exists binding agent to make with optional, and count by weight percentage, contain diclofenac potassium 50%～80% in the principal agent layer, filler 10%～30%, binding agent 0～30%, described sustained release coating layer is by slow releasing agent, antiplastering aid, the optional porogen that exists, the optional plasticizer that exists, the optional opacifier that exists is made, and porogen and plasticizer exist one of at least in the two, count by weight percentage, contain slow releasing agent 60%～85% in the sustained release coating layer, antiplastering aid 5%～30%, porogen 0～10%, plasticizer 0～10%, opacifier 0～10%.
2. diclofenac potassium sustained-release pellet according to claim 1, wherein said slow releasing agent are selected from ethyl cellulose, acrylic resin, the cellulose acetate one or more.
3. diclofenac potassium sustained-release pellet according to claim 1, wherein:
Described filler is selected from lactose, sucrose, starch, DI-CALCIUM PHOSPHATE, mannitol, sorbitol, microcrystalline Cellulose and the Pulvis Talci one or more;
Described antiplastering aid is selected from Pulvis Talci, magnesium stearate, micropowder silica gel and the sodium lauryl sulphate one or more;
Described porogen is selected from hypromellose, hyprolose, polyethylene glycol 6000 and the polyvidone one or more;
Described plasticizer is selected from glycerol, propylene glycol, polyethylene glycols, citron triethylenetetraminehexaacetic acid fat, dimethyl phthalate, triacetin and the Oleum Ricini one or more;
Described binding agent is selected from sodium carboxymethyl cellulose, polyvidone, hypromellose and the sucrose one or more;
Described opacifier is a titanium dioxide.
4. according to each described diclofenac potassium sustained-release pellet of claim 1-3, wherein said celphere is made up of sucrose, starch or microcrystalline Cellulose, and the size of described celphere is 0.35～1.12mm.
5. diclofenac potassium sustained-release pellet according to claim 4, the size of wherein said celphere are 0.6～0.9mm.
6. a Piclofenac potassium sustained release capsule is characterized in that loading the capsule that forms by each described diclofenac potassium sustained-release pellet of claim 1-5, contains diclofenac potassium 50～200mg in every capsules.
7. Piclofenac potassium sustained release capsule according to claim 6 contains diclofenac potassium 100mg in wherein every capsules.
8. a method for preparing claim 6 or 7 described Piclofenac potassium sustained release capsules is characterized in that comprising the steps:
(1) celphere is joined in the comminutor, spray ethanol or water or binder solution moistening, add the mixture of principal agent and filler again, make ganoid pastille micropill; Perhaps use 60%～95% dissolve with ethanol solution principal agent, filler, binding agent, make coating solution, celphere is joined in the comminutor, the coating solution that sprinkling prepares gets the pastille micropill in the celphere surface after the drying;
(2) with 60%～95% dissolve with ethanol solution slow releasing agent, porogen, plasticizer, antiplastering aid, opacifier, make sustained release coating liquid;
(3) the sustained release coating liquid for preparing is evenly sprayed on the pastille micropill surface for preparing, get diclofenac potassium sustained-release pellet after the drying;
(4) diclofenac potassium sustained-release pellet that step (3) is made incapsulates in the shell, gets Piclofenac potassium sustained release capsule.
9. method according to claim 8 is characterized in that slow-release micro-pill adopts centrifugal coating pelletizing machine, High Speed Stirring Machine, extrudes spheronizator, fluidized bed coating granulator or the preparation of efficient film coating pan.
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| CN101804030B (en) * | 2009-02-12 | 2012-09-05 | 杭州赛利药物研究所有限公司 | Sodium dichlorophenolate micro-pill pharmaceutical preparation and preparation method thereof |
| CN101862297B (en) * | 2009-04-14 | 2012-07-25 | 上海医药工业研究院 | Water-insoluble medicine sustained-release pellet, sustained-release orally disintegrating tablet thereof and preparation method thereof |
| CN101612140B (en) * | 2009-07-13 | 2011-12-14 | 浙江金华康恩贝生物制药有限公司 | Preparation method of diclofenac potassium sustained-release pellet capsule |
| CN102188388B (en) * | 2010-03-12 | 2012-12-26 | 南京易亨制药有限公司 | Diclofenac sodium sustained-release pellet preparation and preparation method thereof |
| CN102266292B (en) * | 2011-07-14 | 2013-03-13 | 浙江金华康恩贝生物制药有限公司 | Matrix diclofenac potassium sustained-release pellet capsules and production process thereof |
| CN102860987B (en) * | 2012-09-20 | 2015-06-17 | 南京长澳制药有限公司 | Diclofenac sodium sustained-release capsule and preparation method thereof |
| CN109602712A (en) * | 2019-01-23 | 2019-04-12 | 上海衡山药业有限公司 | A kind of slow-release material and preparation method thereof containing C14H10Cl2NNaO2 |
| CN115317464B (en) * | 2022-09-01 | 2023-08-08 | 苏州弘森药业股份有限公司 | Potassium diclofenac microcapsule and preparation method thereof |
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